Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process

OVERVIEW
Two-day course is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions.

For more than 30 years, the 510(k) process has consistently done a good job of protecting patients against unsafe products. The process is well designed to assess the safety and effectiveness of low and moderate risk medical devices whose risks are well understood from experience with similar devices. Various industry trade groups and associations are now somewhat concerned that the number and scope of FDA's recently proposed 510(k) changes could negatively impact the agency's mission to ensure American patients have timely access to safe and effective medical technologies.

In comments submitted to FDA in response to the agency's release in August 2010 of more than 60 proposals to change the 510(k) process, industry has advocated that instead of implementing an extensive list of potentially disruptive proposals, FDA should focus on the proposals the agency has advanced that enjoy broad agreement and consensus, such as: increased reviewer training, development of specific and relevant guidance documents, and enhancements or improvements to the de novo review pathway, among other suggestions. This 1-day primer and course will provide an update to these proposals as appropriate and where we stand but more importantly, provide direction, guidance and clarity on preparing for, executing and submitting your 510(k) application.

WHO WILL BENEFIT:

• CEOs &CFOs in medical device companies
• VPs, Directors and Heads of Regulatory Affairs
• VPs, Directors and Heads of Clinical Affairs
• Senior and line Marketing and Sales Management
• Regulatory Consultants
• Risk Managers
• Engineering & R&D
• Professionals involved with premarket notification to the FDA
• R&D personnel involved in approving the design of medical devices
• Medical device sales and marketing personnel
• Production & Operations

OBJECTIVES:
This seminar will provide an overview and in-depth snapshot of the process for preparing for and managing an FDA inspection efficiently, effectively and successfully. You will learn and understand how FDA trains its investigators and inspectors so that you can prepare and always be in a state of readiness. Attendees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the FDA inspectional process, strategy, the tools to be used to assess and gauge state of preparation and readiness, including:

• Know the differences between the Traditional, Special and Abbreviated submissions
• Understand Substantial Equivalence and how it is applied
• Who is required to submit the application to FDA
• Where to submit the 510(k) and what to expect with the review and approval process
• When it is and is not required if you are a device company
• Exemptions to the submission process and special considerations
• How to locate a "predicate" device and go through the content and format of the 510(k)
• Understand the De Novo process and the expectations for possibly marketing a low risk device
• Understand the potential impact of FDA's proposed changes to the 510(k) process and why manufacturers need to pay attention

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